Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318383
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2006-04-24
Brief Title:
Efficacy of NicVAX in Smokers Who Want to Quit Smoking
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
A Phase 2 Multi-center Randomized Double-blinded Placebo-controlled Study to Assess Efficacy of 3-Aminomethylnicotine-PAeruginosa r-Exoprotein A Conjugate Vaccine NicVAX in Smokers Who Want to Quit Smoking
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking In addition two different formulations and dosing schedules will be studied to select the dose and dosing schedule which generates the highest level of anti-nicotine antibodies The primary study period is 12 months which was extended by amendment to include up to 2 years of observations
Detailed Description:
Cigarette smoking is responsible for over 400000 1 out of every 5 deaths in the United States each year Most smokers are aware of the health consequences and want to quit but have difficulty doing so Only 3-5 of smokers who quit on their own are successful Since the vast majority of those who attempt to quit will fail the need for better approaches to smoking cessation is clear and urgent A safe and effective means of blocking the effects of nicotine would be of considerable interest as a potential treatment for tobacco use Vaccination to produce nicotine-specific antibodies may be viewed as an alternative method of blocking nicotine effects Nicotine is a small molecule that does not elicit an immune response in animals of humans In order for the immune system to respond to this hapten nicotine can be combined or bound to a larger molecule in a unique manner so that an immune response is mounted against nicotine Nabi Biopharmaceuticals has developed a conjugate vaccine NicVAX that consists of 3-aminomethylnicotine bound to Pseudomonas aeruginosa exoprotein A an exotoxin that has been made non-toxic by an amino acid deletion Subjects will be randomized to one of four treatment groups
Within each treatment group 75 subjects will be randomized in a 21 ratio NicVAXPlacebo yielding a total of 50 active and 25 placebo subjects for each treatment group There will be 12 subjects enrolled in a fifth open label arm to evaluate immunogenicity A quit date will be set at the end of week 7 or at the end of week 5 depending on the dosing schedule Continuous abstinence will be measured between the end of week 18 and the end of week 26
Within each treatment group 75 subjects will be randomized in a 21 ratio NicVAXPlacebo yielding a total of 50 active and 25 placebo subjects for each treatment group There will be 12 subjects enrolled in a fifth open label arm to evaluate immunogenicity A quit date will be set at the end of week 7 or at the end of week 5 depending on the dosing schedule Continuous abstinence will be measured between the end of week 18 and the end of week 26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA017894-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DA017894-01A1 |